K834458 is an FDA 510(k) clearance for the EMIT D.A.U. URINE CANNABINOID ASSAY. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on June 21, 1984, 185 days after receiving the submission on December 19, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K834458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1983 |
| Decision Date | June 21, 1984 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |